ReviewMayo Clinic proceedings. Digital health2025
Global Harmonization of Artificial Intelligence-Enabled Software as a Medical Device Regulation: Addressing Challenges and Unifying Standards.
Review in Mayo Clinic proceedings. Digital health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Evidence and Future Directions for Pediatric Health Care Chatbots: Systematic Review.Journal of medical Internet research · 2026Pooled it
- Two-decade dialogue between artificial intelligence and osteoporosis: research trajectories and frontier projections under bibliometric and visual analysis.Frontiers in medicine · 2025Pooled it
- When the algorithm passes the test but fails the patient.PLOS digital health · 2026Article
- Artificial Intelligence in the Management of Facial Palsy: A Narrative Review Across the Care Continuum.Plastic surgery (Oakville, Ont.) · 2026Review
- QHealthcare (Basel, Switzerland) · 2026Article
- Quantum-Augmented Federated AI for Adaptive Pharmacogenomic Precision Oncology: A Perspective.ACS pharmacology & translational science · 2026Review
- Applications of Artificial Intelligence in Cancer Diagnosis and Treatment.Cancer medicine · 2026Review
- Foundation for Artificial Intelligence-Driven Democratization of Healthcare Access.Learning health systems · 2026Article
- AI/ML-Assisted SERS Biosensing for Biomolecular Detection: From Direct Spectral Response to Integrated Diagnostic Systems.Biosensors · 2026Review
- Patient Cognitive Bias in Large Language Model-Supported Health Consultations: Simulation-Based Comparative Study.Journal of medical Internet research · 2026Article
- Nanostructured electrode materials and flexible-substrate engineering for wearable multi-analyte biosensors in diabetes monitoring and personalized care: a comprehensive review.Journal of materials science. Materials in medicine · 2026Review
- Artificial intelligence in drug research and development: a review of methods and applications in drug repurposing.Briefings in bioinformatics · 2026Review
- Artificial intelligence in mobile health applications: A comprehensive review of its role in diabetes care.World journal of methodology · 2026Review
- Approval of AI-Based Medical Devices in China From 2020 to 2025: Retrospective Analysis.JMIR medical informatics · 2026Article
- Stimuli-Responsive Nanomaterial-Based Biosensor Structures for Wound Care: pH, ROS, and Temperature Sensing Strategies.Micromachines · 2026Review
- Artificial Intelligence in Orthopaedics: Clinical Performance, Limitations, and Translational Readiness-A Review.Journal of clinical medicine · 2026Review
- Regulation of clinical Artificial Intelligence (AI) in the Age of Agents: Unconfined Non-Deterministic Clinical Software (UNDCS) systems for healthcare.NPJ digital medicine · 2026Article
- Distributed Precision Stroke Care: Artificial Intelligence-Driven Stroke Management Using Multimodal Sensor Data.Stroke · 2026Review
- FDA-Cleared Artificial Intelligence Medical Devices in Orthopaedic Surgery.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2026Article
- A six-level clinical autonomy framework for artificial intelligence in dentistry.Frontiers in oral health · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The growing incorporation of artificial intelligence (AI) into medical device software offers substantial prospects and regulatory hurdles. As AI software as a medical device (AI-SaMD) continues to advance, ensuring its safety, effectiveness, and security is paramount. Nevertheless, the regulatory environment needs more cohesion, with various regions implementing diverse strategies. This paper underscores the necessity for globally harmonized AI-SaMD regulations by examining key regulatory frameworks from the United States, the European Union, China, and Australia. The article also explores crucial elements for harmonization, including algorithm transparency, risk management, data security, and clinical evaluation. Furthermore, the paper advocates for implementing international standards and global data security protocols, emphasizing the significance of cross-border cooperation to ensure the worldwide safety and efficacy of AI-SaMD.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.